BILL ANALYSIS

 

 

 

S.B. 1127

By: Van de Putte

Public Health

Committee Report (Unamended)

 

 

 

BACKGROUND AND PURPOSE

 

The Texas State Board of Pharmacy is the state agency responsible for the licensure and discipline of Texas pharmacists and pharmacies. The board's main responsibility is to protect the public's health, safety, and welfare by fostering the provision of quality pharmaceutical care to the citizens of Texas.  In meeting this goal, the board randomly samples products that have been compounded by pharmacies and tests such products for accuracy of compounding.  As part of the testing, the board collects the formulas used by the pharmacy for compounding a product.  Under current law, all information the board collects during this process is considered public information for purposes of the Public Information Act.  However, many of the formulas and other processes used in compounding such products are trademarked and, therefore, the information collected is proprietary.

 

S.B. 1127 provides that all reports, formulas, and test results of samples of products compounded by pharmacies obtained by the board are confidential and are not public information, but authorizes the board to disclose the confidential information under certain circumstances.

RULEMAKING AUTHORITY

 

It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution.

ANALYSIS

 

S.B. 1127 amends the Occupations Code to authorize reports, records, formulas, and test results of samples of products compounded by pharmacies obtained by the Texas State Board of Pharmacy to be provided to the pharmacy that compounded the product but otherwise makes such information confidential, specifying that such information does not constitute public information for purposes of open records laws.  The bill authorizes the board to create, use, or disclose statistical information from the test results of samples of compounded products.

 

S.B. 1127 authorizes the board to disclose such confidential information in a disciplinary hearing before the board or in a subsequent trial or appeal of a board action or order, to a pharmacist licensing or disciplinary authority of another jurisdiction, or under a court order.  The bill requires the board to require a pharmacy to recall a compounded product and authorizes the board to release the results of the tests of the samples of the compounded product, if the board determines that the test results indicate a patient safety problem that may involve potential harm to a patient and that release of the test results is necessary to protect the public.  The bill requires the board to release such test results if a pharmacy is unable to or does not recall the compounded product within 48 hours after the board's request for a recall.

EFFECTIVE DATE

 

On passage, or, if the act does not receive the necessary vote, the act takes effect September 1, 2009.